simvastatin

Generic: simvastatin

Labeler: preferred pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler preferred pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 20 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8342
Product ID 68788-8342_e1169d33-e736-4322-acdd-cf52f7eb042c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2026-12-31
Marketing Start 2023-02-03

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888342
Hyphenated Format 68788-8342

Supplemental Identifiers

RxCUI
312961
UNII
AGG2FN16EV
NUI
N0000175589 N0000000121

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name simvastatin (source: ndc)
Generic Name simvastatin (source: ndc)
Application Number ANDA078103 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8342-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8342-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8342-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8342-9)
source: ndc

Packages (4)

68788-8342-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8342-1) 68788-8342-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8342-3) 68788-8342-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8342-6) 68788-8342-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8342-9)

Ingredients (1)

simvastatin (20 mg/1)

Linked Drug Pages (1)

SIMVASTATIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e1169d33-e736-4322-acdd-cf52f7eb042c", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["312961"], "spl_set_id": ["3f6fad0b-0278-433f-86db-761b673a5803"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8342-1)", "package_ndc": "68788-8342-1", "marketing_start_date": "20230203"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8342-3)", "package_ndc": "68788-8342-3", "marketing_start_date": "20230203"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8342-6)", "package_ndc": "68788-8342-6", "marketing_start_date": "20230203"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8342-9)", "package_ndc": "68788-8342-9", "marketing_start_date": "20230203"}], "brand_name": "SIMVASTATIN", "product_id": "68788-8342_e1169d33-e736-4322-acdd-cf52f7eb042c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-8342", "generic_name": "SIMVASTATIN", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMVASTATIN", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA078103", "marketing_category": "ANDA", "marketing_start_date": "20230203", "listing_expiration_date": "20261231"}